Gradual vs. Abrupt Cessation Treatment for Smoking
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ClinicalTrials.gov Identifier: NCT00297492 |
Recruitment Status :
Completed
First Posted : February 28, 2006
Results First Posted : September 5, 2012
Last Update Posted : September 20, 2013
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Sponsor:
University of Vermont
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
John Hughes, University of Vermont
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Smoking Cessation |
Interventions |
Behavioral: Reduction Phone Counseling Behavioral: Abrupt Phone Counseling Behavioral: Minimal Abrupt Phone Counseling Drug: Pre-Quit Nicotine Lozenges Drug: Post-Quit Nicotine Lozenges |
Enrollment | 750 |
Participant Flow
Recruitment Details | Participants were recruited using advertisements targeting smokers who wanted to quit smoking gradually. Advertisements were placed in newspapers in two cities in South Carolina and one city in New Mexico. |
Pre-assignment Details | Enrolled sample size of 750; 4 were excluded because found to be ineligible after enrollment. |
Arm/Group Title | Gradual Reduction | Abrupt Cessation | Minimal Intervention |
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Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date | Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date | Minimal intervention to mimic intervention at a primary care office |
Period Title: Set Quit Date | |||
Started | 297 | 299 | 150 |
Completed | 290 | 286 | 145 |
Not Completed | 7 | 13 | 5 |
Reason Not Completed | |||
Lost to Follow-up | 7 | 13 | 5 |
Period Title: 6 Month Follow-up | |||
Started | 290 | 286 | 145 |
Completed | 227 | 237 | 118 |
Not Completed | 63 | 49 | 27 |
Reason Not Completed | |||
Lost to Follow-up | 63 | 49 | 27 |
Baseline Characteristics
Arm/Group Title | Gradual Reduction | Abrupt Cessation | Minimal Intervention | Total | |
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Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date | Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date | Minimal intervention to mimic intervention at a primary care office | Total of all reporting groups | |
Overall Number of Baseline Participants | 297 | 299 | 150 | 746 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 297 participants | 299 participants | 150 participants | 746 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
273 91.9%
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276 92.3%
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139 92.7%
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688 92.2%
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>=65 years |
24 8.1%
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23 7.7%
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11 7.3%
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58 7.8%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 297 participants | 299 participants | 150 participants | 746 participants | |
48 (13) | 48 (12) | 47 (13) | 48 (13) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 297 participants | 299 participants | 150 participants | 746 participants | |
Female |
159 53.5%
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165 55.2%
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80 53.3%
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404 54.2%
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Male |
138 46.5%
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134 44.8%
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70 46.7%
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342 45.8%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 297 participants | 299 participants | 150 participants | 746 participants |
297 | 299 | 150 | 746 |
Outcome Measures
Adverse Events
Limitations and Caveats
Our projected incidence of abstinence was higher than what was actually observed, leading to lower statistical power than expected.
More Information
Results Point of Contact
Name/Title: | Dr. John Hughes |
Organization: | University of Vermont |
Phone: | 802-656-9610 |
EMail: | John.Hughes@uvm.edu |
Responsible Party: | John Hughes, University of Vermont |
ClinicalTrials.gov Identifier: | NCT00297492 |
Other Study ID Numbers: |
R01DA011557-07 ( U.S. NIH Grant/Contract ) R01DA011557-07 ( U.S. NIH Grant/Contract ) |
First Submitted: | February 24, 2006 |
First Posted: | February 28, 2006 |
Results First Submitted: | May 31, 2012 |
Results First Posted: | September 5, 2012 |
Last Update Posted: | September 20, 2013 |